Combined Aerobic Exercise and Resistance Training (AE + RT) for Mild Cognitive Impairment

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
The University of New Brunswick, Fredericton, CanadaMild Cognitive ImpairmentCombined Aerobic Exercise and Resistance Training (AE + RT) - Behavioral
Eligibility
60 - 90
All Sexes
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Study Summary

This trial will test the feasibility of delivering exercise and cognitive interventions to older adults at risk for developing Alzheimer's Disease and Related Dementias in the home, as well as assess participants' preferences for these interventions.

Eligible Conditions
  • Mild Cognitive Impairment

Treatment Effectiveness

Study Objectives

2 Primary · 64 Secondary · Reporting Duration: Baseline, post-intervention at 4 months, and follow-up at 10 months

10 months follow-up
Trial Experience
Baseline
Age
Assessment Tolerability
COVID-19 Questionnaire
Height
Intervention Preference
Sex
Short Test of Functional Health Literacy in Adults (STOFHLA)
Weight
Month 10
Change in 14-item Mediterranean Diet Assessment (MDA-14)
Change in 15-item Boston Naming Test (BNT)
Change in 18-item Pittsburgh Sleep Quality Index (PSQI-18)
Change in ADAS-Cog Delayed Word Recall
Change in ADAS-Cog Immediate Word Recall
Change in ADAS-Cog Orientation
Change in ADAS-Cog Word Recognition
Change in Clinical Dementia Rating Scale (CDR)
Change in Clinical Frailty Scale (CFS)
Change in Cognitive Functional Composite 2 (CFC-2)
Change in Constant Fatigue
Change in Digit Span Backward Test
Change in Eating Pattern Self-Assessment
Change in Falls and Balance
Change in Functional Assessment of Currently Employed Technology Scale (FACETS)
Change in Generalized Anxiety Disorder 7 (GAD 7)
Change in Geriatric Depression Scale (GDS-30)
Change in Health Status and Self-Perception
Change in Hearing
Change in Hip Circumference
Change in Lawton-Brody Instrumental Activities of Daily Living (IADL) scale
Change in Life Space Questionnaire (LSQ)
Change in Logical Memory I
Change in Logical Memory II
Change in Mayo Fluctuation Scale
Change in Medications
Change in Neck Circumference
Change in Nutrition
Change in Oral Trail Making Test (TMT) A
Change in Oral Trail Making Test (TMT) B
Change in Oral version of the Digit Symbol Modalities Test
Change in Physical Activity Scale for the Elderly (PASE)
Change in Questionnaire for Vitamin D intake
Change in Short Form quality of life questionnaire (SF-36)
Change in Sit to Stand Test (STST) performance
Change in Sleep
Change in Telephone Cognitive Screen (TCogS)
Change in The Delis-Kaplan Executive Function System (DKEFS) phonemic fluency test
Change in The Delis-Kaplan Executive Function System (DKEFS) semantic fluency test
Change in Vision
Change in Work and Sleep Diary (WSD)
Change in blood pressure
Change in dual-task gait
Change in fall history
Change in heart rate
Change in remote version of the Montreal Cognitive Assessment (MoCA)
Change in seated dual task
Change in single-task gait
Change in waist circumference
Chronic Diseases
Functional Activities Questionnaire
Monitored from start of study until end of study
Adverse Events
Month 8
Biomarkers of Alzhiemer's Disease and Related Diseases
Post-intervention at 4 months
Intervention Adherence
Month 10
Data Loss
Recruitment Rate
Retention Rate

Trial Safety

Trial Design

4 Treatment Groups

Control Exercise Training and Cognitive Intervention Training
1 of 4
Exercise Intervention Training and Control Cognitive Training
1 of 4
Exercise Intervention Training and Cognitive Intervention Training
1 of 4
Control Exercise Training and Control Cognitive Training
1 of 4

Active Control

Experimental Treatment

Non-Treatment Group

60 Total Participants · 4 Treatment Groups

Primary Treatment: Combined Aerobic Exercise and Resistance Training (AE + RT) · Has Placebo Group · N/A

Exercise Intervention Training and Cognitive Intervention TrainingExperimental Group · 2 Interventions: Cognitive Training (NeuropeakTM), Combined Aerobic Exercise and Resistance Training (AE + RT) · Intervention Types: Behavioral, Behavioral
Control Exercise Training and Cognitive Intervention TrainingActiveComparator Group · 2 Interventions: Cognitive Training (NeuropeakTM), Control Balance and Toning Exercise Training (BAT) · Intervention Types: Behavioral, Behavioral
Control Exercise Training and Control Cognitive TrainingPlaceboComparator Group · 2 Interventions: Control Cognitive Training of Website Searching and Video Watching (WS+V), Control Balance and Toning Exercise Training (BAT) · Intervention Types: Behavioral, Behavioral
Exercise Intervention Training and Control Cognitive TrainingActiveComparator Group · 2 Interventions: Combined Aerobic Exercise and Resistance Training (AE + RT), Control Cognitive Training of Website Searching and Video Watching (WS+V) · Intervention Types: Behavioral, Behavioral

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: baseline, post-intervention at 4 months, and follow-up at 10 months

Who is running the clinical trial?

University of Western Ontario, CanadaOTHER
163 Previous Clinical Trials
318,922 Total Patients Enrolled
University of New BrunswickLead Sponsor
19 Previous Clinical Trials
2,370 Total Patients Enrolled
Horizon Health NetworkOTHER
26 Previous Clinical Trials
14,398 Total Patients Enrolled
Réseau de Santé Vitalité Health NetworkOTHER
8 Previous Clinical Trials
1,883 Total Patients Enrolled
Universite de MonctonOTHER
9 Previous Clinical Trials
5,161 Total Patients Enrolled
Western University, CanadaOTHER
202 Previous Clinical Trials
36,699 Total Patients Enrolled
Chris McGibbon, PhDPrincipal InvestigatorUniversity of New Brunswick

Eligibility Criteria

Age 60 - 90 · All Participants · 11 Total Inclusion Criteria

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Frequently Asked Questions

What are the projected results from this clinical exploration?

"This medical trial's primary goal, which will be tracked for 4 months post-intervention, is to measure patients' preference of the intervention. Secondary objectives include assessing changes in quality of life through a 36-item questionnaire (SF-36), clinical frailty by using a 9 point scale (CFS), and dietary habits via a 14 item survey (MDA-14)." - Anonymous Online Contributor

Unverified Answer

How many individuals can participate in this research project?

"Affirmative. The clinicaltrials.gov website verifies that this investigation is actively recruiting participants, which was initially posted on July 28th 2021 and revised lastly on December 7th 2021. 64 individuals are required for the trial to be held at one site." - Anonymous Online Contributor

Unverified Answer

Does this evaluation encompass elderly participants over 85 years old?

"In accordance with this clinical trial's inclusion criteria, the age range for participating patients is between 60 and 90 years of age." - Anonymous Online Contributor

Unverified Answer

Who would benefit most from participating in this trial?

"This clinical trial is enlisting 64 elderly individuals exhibiting cognitive deterioration, aged between 60 and 90. To be eligible for participation, applicants must satisfy the following criteria: comply with all home-based assessments and other procedures of the clinical trial; possess a Family Physician; have access to email services as well as internet connectivity; reside in a house or an apartment within their local community; employ either a tablet computer device or pc at home; communicate fluently in English and/or French (both written & spoken); move independently over 10 metres using any mobility aid if needed; suffer from Mild Cognitive Impairment (MCI) or Subjective" - Anonymous Online Contributor

Unverified Answer

Are individuals being enrolled in the trial at this present moment?

"Affirmative. Clinicaltrials.gov data indicates that the trial, which was first posted on July 28th 2021 and last revised December 7th 2021 is currently seeking volunteers. 64 patients are needed from a single clinical site." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.